Project Summary

Each year in the United States, more than 16 million people undergo same-day surgery and recover at home. While pain after surgery is a common experience, determining the best way to treat it remains unclear. This is an important question as many individuals continue to report having pain that is of moderate severity or higher in the days that follow surgery, and more than half report inadequate pain control.

Clinicians typically choose between two options when prescribing medications to manage acute pain after surgery. One way to treat acute pain after surgery is by taking nonsteroidal anti-inflammatory drugs (NSAIDs) with acetaminophen. The alternative is taking low-dose opioid medications with acetaminophen. Both NSAID and opioid medications may help to relieve pain, but both have important side effects as well. However, there are currently no studies that provide data to help patients and their clinicians decide which of these strategies is the best.

This study will compare how well NSAID and opioid treatments help patients control their pain as they recover at home after surgery. The objective of this study is to identify which type of pain medication works the best at relieving pain and has the least amount of associated harm. The first aim of the study is to compare how well NSAID and opioid treatments relieve acute pain after surgery. The second aim of the study is to compare the harms of these two treatments. The third aim of the study is to compare the effects of NSAID and opioid treatments on other important outcomes related to quality of life and recovery after surgery.

Findings from this study will help people undergoing surgery, their families, and their doctors make choices about how to manage pain and take the best type of pain medicine.

The project team plans to enroll 900 adult patients who undergo scheduled surgery at four health systems and who anticipate needing medications to treat pain after surgery. The team will recruit these patients by speaking to them during the time between when they sign up for surgery with their surgeon and the day of their surgery. The focus of this study will be three types of procedures that are commonly performed in the United States: gallbladder removal, hernia repair, and breast lump removal. Researchers will assign patients by chance on the day of surgery to receive either NSAIDs or opioids to treat pain after their procedure. Patients will be aware of which type of pain medication they will take.

The team will contact patients for up to six months after surgery to examine their experiences of taking each medication. The team will ask patients questions using surveys that can be completed on smartphones or by telephone calls. Patients who do not have smartphones will be provided one. Patients and stakeholders helped choose the questions that will be asked to ensure that this study captures what is most important to these groups. For the primary outcome, the team will measure pain reported by patients after surgery every day for the first seven days and then at one month, and six months. For the primary safety outcome, the team will measure side effects reported by patients after surgery every day for the first seven days and then at one month.

The team will rely on patients to report other important outcomes after surgery. Recovery will be measured at one week. Sleep disturbances will be measured at one month. Pain-related function and quality of life will be measured at three months. Misuse of opioids will be evaluated at three and six months. The team will determine whether individuals develop issues with substance use at six months. The team will measure complications after surgery by review of the electronic health record at six months. Finally, the team will assess the need for ongoing opioid medications at six months by reviewing opioid prescription data.

To translate the knowledge generated from the study into action, the research team is collaborating with multiple groups to design and conduct the study and share study results, including patients who have experienced pain after surgery, healthcare providers, payers, community groups, and other researchers. Study results will provide much-needed information to improve the care for millions of patients in the United States undergoing ambulatory surgery each year.

Project Information

Mark Bicket MD, PHD
University of Michigan
$4,098,145 *

Key Dates

36 months *
December 2021
2021

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: December 2, 2021